Protocol summary

Study aim
To determine the most effective and stable Dry Needling (DN) technique among LI4 & TE5 acupoints DN or wrist flexor DN, for Spasticity and function of stroke patients.
Design
A randomized, double-blinded clinical trial with a parallel group design of 20 patients.
Settings and conduct
Stroke patients are recruited through the physiotherapy centers. Demographic data and outcome variables are recorded at first session. Blinding is performed on patients, examiners and performers. The patient is not aware of the type of treatment group. Examiner is not aware of the treatment method, the allocation and DN is performed by a blinded-researcher to the examination results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age≥18 years old, First-ever stroke, Disease duration of at least six months, Wrist flexor MMAS spasticity score ≥1, Active and passive ROM of the involved wrist is at most 10% less than the non-involved side. Exclusion criteria: Diabetes, Inability to follow the therapist's instructions, Have contraindications to DN, Have participation simultaneously in another clinical trial, Have injections with BTXA in the 6 months preceding the study, Taking antispastic drug
Intervention groups
Intervention group 1: the needle applies in two acupoints of forearm and hand, including LI4 and TE5."Intervention group 2: the DN is performed at the motor points of flexor carpi radialis and flexor carpi ulnaris muscles.The intervention used is DN, in which the acupuncture needle is inserted deeply into a point in the soft tissue without injecting any substance for one minute for each point. The needle is moved in different directions to the surface and depth of the tissue. The number of treatment sessions is three sessions during a week.
Main outcome variables
Spasticity(Modified Modified Ashworth Scale); motor function(Fugl-Meyer assessment); Active/Passive Range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200913048706N1
Registration date: 2021-01-14, 1399/10/25
Registration timing: registered_while_recruiting

Last update: 2021-01-14, 1399/10/25
Update count: 0
Registration date
2021-01-14, 1399/10/25
Registrant information
Name
Najmeh Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3433 2429
Email address
najmeh_nazari@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-26, 1399/08/05
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the short term effects of wrist flexor dry needling versus LI4 & TE5 acupuncture points dry needling on upper limb spasticity and function, in stroke patients: A Double-Blinded Randomized Clinical Trial
Public title
The effect of dry needling technique on spasticity and function in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years old First-ever stroke resulted in hemiplegia Disease duration of at least six months Wrist flexor Modified Modified Ashworth Scale (MMAS) spasticity score ≥1 Active and passive range of motion of the involved wrist is at most 10% less than the non-involved side
Exclusion criteria:
Have neurological disorders or diabetes Inability to follow the therapist's instructions Have contraindications to Dry Needling Have participation simultaneously in another clinical trial Have injections with botulinum toxin in the 6 months preceding the study Taking antispastic drug
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
According to the number of patients in each group, the particular sort of treatment, either "wrist flexor dry needling" or "LI4&TE5 acupuncture points dry needling," is written on a piece of paper, and the paper is placed in Opaque sealed envelopes. The envelopes are then mixed. At the first visit session of each individual, the therapist who will not be involved in outcomes assessment will randomly select one of the envelopes. Based on the written sort of treatment specified, the therapist will do the patient's particular treatment. If any of the patients, for any reason, is omitted from the study, one envelope with the particular topic will be added again by the examiner, and they will be mixed again.
Blinding (investigator's opinion)
Double blinded
Blinding description
Although at first, the necessary explanation about the aims of the project and the existence of two groups are given to the patients, no explanation is given to them about the difference between the treatment methods. Besides, the patient's treatment sessions will be arranged so that the two groups' patients have no contact with each other and are not aware of the other group's treatment method. In this way, patients are blind regarding the treatment method. In addition, the allocation of participants into each of the treatment groups will be done by the therapist who performed the DN, and their clinical evaluation will be performed by another examiner who is not aware of the treatment group. So the examiner also is blind to the specific treatment method of each participant.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Nursing and Midwifery & Rehabilitation Schools- Tehran University of Medical Sci
Street address
Quds Ave., Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
2181455618
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.TUMS.FNM.REC.1399.123

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome

Primary outcomes

1

Description
Spasticity
Timepoint
Before intervention, immediately after intervention, and one week after intervention
Method of measurement
Modified Modified Ashworth Scale

2

Description
Function
Timepoint
Before intervention, immediately after intervention, and one week after intervention
Method of measurement
Fugl-Meyer assessment

Secondary outcomes

1

Description
Active Range Of Motion(ROM)
Timepoint
Before intervention, immediately after intervention, and one week after intervention
Method of measurement
Goniometer

2

Description
Passive Range Of Motion(ROM)
Timepoint
Before intervention, immediately after intervention, and one week after intervention
Method of measurement
Goniometer

Intervention groups

1

Description
Intervention group 1:wrist flexor dry needling including flexor carpi ulnaris and flexor carpi radialis in supine position and forearm in supination with filiform needles. The technique is done in the Fast in - Fast out method for one minute for each muscle / point. The number of treatment sessions is three sessions during a week.
Category
Rehabilitation

2

Description
Intervention group 2: LI4 & TE5 acupuncture points dry needling in supine position and forearm in pronation with filiform needles. The technique is done in the Fast in - Fast out method for one minute for each muscle / point. The number of treatment sessions is three sessions during a week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurological physiotherapy Clinic, School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Najmeh Nazari
Street address
Department of physiotherapy, School of Rehabilitation., Pich.e.Shemiran., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
Najmeh_Nazari@outlook.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahrayian
Street address
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences and Health Services, 6th Floor, Central University Organization, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Najmeh Nazari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Department, School of Rehabilitation, Pich-e-Shemiran., Enghelab St.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 5132
Fax
+98 21 7772 7009
Email
Najmeh_Nazari@outlook.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Najmeh Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Department, School of Rehabilitation, Pich-e-Shemiran., Enghelab St
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 5132
Email
Najmeh_Nazari@outlook.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Najmeh Nazari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Department, School of Rehabilitation, Pich-e-Shemiran., Enghelab St.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 5132
Fax
+98 21 7772 7009
Email
Najmeh_Nazari@outlook.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The raw data of research and its analysis will be available to researchers if they request it.
When the data will become available and for how long
After the publication of articles resulting from the research.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
The data are available only to other researchers to study and evaluate treatment outcomes.
From where data/document is obtainable
By sending an email to the corresponding author.
What processes are involved for a request to access data/document
Sending an Email to the corresponding author and request the data.
Comments
Loading...